The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac S315.
| Device ID | K921296 |
| 510k Number | K921296 |
| Device Name: | ADAC S315 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | ADAC LABORATORIES JELLINGVEJ 5 9230 SVENSTRUP Denmark, DK |
| Contact | Jeppe Vangsgaard |
| Correspondent | Jeppe Vangsgaard ADAC LABORATORIES JELLINGVEJ 5 9230 SVENSTRUP Denmark, DK |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-05-28 |